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NCT00067808 · OUTCOME

Participant Responses

Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) · Source last updated 2012-08-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Response to treatment after 8 weeks of therapy

What was measured

Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 109/ L, and a platelet count \> 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to \>100 x 109/L; and 'No Response'.

Analysis population: As treated: 124 patients completed treatment.

Groups in this outcome

Decitabine 10 mg/m2 IV

10 mg/m2 by vein (IV) over 1 hour daily for 10 days

Decitabine 20 mg/m2 IV

20 mg/m2 IV over 1 hour daily for 5 days

Decitabine 20 mg/m2 SQ

20 mg/m2 subcutaneous (SQ) daily for 5 days

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Decitabine 10 mg/m2 IV17
Decitabine 20 mg/m2 IV93
Decitabine 20 mg/m2 SQ14

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Decitabine 10 mg/m2 IV4Not reportedNot reportedNot reportedNot reported
Decitabine 20 mg/m2 IV47Not reportedNot reportedNot reportedNot reported
Decitabine 20 mg/m2 SQ4Not reportedNot reportedNot reportedNot reported
Other Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Decitabine 10 mg/m2 IV6Not reportedNot reportedNot reportedNot reported
Decitabine 20 mg/m2 IV21Not reportedNot reportedNot reportedNot reported
Decitabine 20 mg/m2 SQ4Not reportedNot reportedNot reportedNot reported
No Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Decitabine 10 mg/m2 IV7Not reportedNot reportedNot reportedNot reported
Decitabine 20 mg/m2 IV25Not reportedNot reportedNot reportedNot reported
Decitabine 20 mg/m2 SQ6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        47
      3. group Id
        OG002
        value
        4
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        4
    title
    Other Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        6
    title
    No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      93
    3. group Id
      OG002
      value
      14
    units
    Participants
description
Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 109/ L, and a platelet count \> 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to \>100 x 109/L; and 'No Response'.
groups
  1. description
    10 mg/m2 by vein (IV) over 1 hour daily for 10 days
    id
    OG000
    title
    Decitabine 10 mg/m2 IV
  2. description
    20 mg/m2 IV over 1 hour daily for 5 days
    id
    OG001
    title
    Decitabine 20 mg/m2 IV
  3. description
    20 mg/m2 subcutaneous (SQ) daily for 5 days
    id
    OG002
    title
    Decitabine 20 mg/m2 SQ
param Type
NUMBER
population Description
As treated: 124 patients completed treatment.
reporting Status
POSTED
time Frame
Response to treatment after 8 weeks of therapy
title
Participant Responses
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice